RecruitingPhase 3NCT06004856

Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Enrollment

195 participants

Start Date

Oct 26, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Primary Immune Thrombocytopenia (ITP)

Summary

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients with Chronic Primary Immune Thrombocytopenia

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Orelabrutinib and a drug called Placebo for people with chronic primary immune thrombocytopenia (itp). The study is currently recruiting participants at 45 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOrelabrutinib

Orelabrutinib once daily (QD)

DRUGPlacebo

Placebo once daily (QD)

Locations(45)

The first affiliated hospital of bengbu medical college

Bengbu, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing CHAO-YANG Hospital Capital Medcal University

Beijing, Beijing Municipality, China

Peking university People's Hospital

Beijing, Beijing Municipality, China

Xinqiao Hospital of Army Medical University

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Zhongshan Hospital Xiamen University

Xiamen, Fujian, China

Gansu Provincial Hospital

Lanzhou, Gansu, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Huazhong University of Science and Technology Union Shenzhen Hospital

Shenzhen, Guangdong, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

North China University of Science and Technology Affiliated Hospital

Tangshan, Hebei, China

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Tongji Medical College Of Hust

Wuhan, Hubei, China

Yichang Central People's Hospital

Yichang, Hubei, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Chenzhou First People's Hospital

Chenzhou, Hunan, China

The Central Hospital of Yongzhou

Yongzhou, Hunan, China

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Wuxi People's Hospital

Wuxi, Jiangsu, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The first Hospital of China Medical University

Shenyang, Liaoning, China

Qilu Hospital Of Shandong University Dezhou Hospital

Dezhou, Shandong, China

Qilu hospital of shandong university

Jinan, Shandong, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Xi'an Central Hospital

Xi’an, Shanxi, China

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi’an, Shanxi, China

Shaanxi Provincial People'S Hospital

Xi’an, Shanxi, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

The Affilated Hospital of Southwest Medical University

Luzhou, Sichuan, China

The Second People's Hospital of Yibin

Yibin, Sichuan, China

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang Uygur Autonomous Region, China

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Provincial Hospital of Chinese Medicine

Hangzhou, Zhejiang, China

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